[사회][단독] Famous pharmaceutical company manipulates raw material capacity…”manufactured arbitrarily”

[앵커]

YTN reports revealed that a famous pharmaceutical company manipulated the dosage of raw materials for antipyretic, depression, and diabetes treatments.

Although we are concerned about the side effects of patients taking it, we cannot even understand how many illegal drugs have been distributed.

This company is also a consigned producer of the Corona 19 vaccine developed by Russia.

This is the exclusive report by reporter Kim Woo-jun.

[기자]

Pharmaceutical company A with annual sales of KRW 100 billion.

It is a place that makes and sells more than 70 kinds of medicines, including consignment production.

It is a production facility facility located in Songdo, Incheon. Recently, it was also selected as a consignment production company for the COVID-19 vaccine treatment.

Antipyretics, depression and diabetes treatments are the main products.

However, as a result of YTN’s interview, it was confirmed that many drugs were manufactured illegally.

The raw material capacity has been arbitrarily changed.

[A 사 출신 관계자 : 제가 예상하기로는 거의(생산량의) 30% 이상은 (불법 제조가) 된다고 봐야죠. 하루에 일일 생산량이 다섯 제품을 한다고 보면, 두 제품 이상은 별지가 붙어서 오는 거죠.]

It is a method of manufacturing diabetes treatment for distribution to factory employees obtained by YTN.

There is a separate’Separate Paper Manufacturing Method’ next to the’Normal Manufacturing Method’ approved by the Ministry of Food and Drug Safety.

The amount of glimepiride that helps secrete insulin is 1,000g in the normal manufacturing method, but only 100g, which is 1/10 in the separate manufacturing method.

The same goes for how antipyretics and arthritis medications are made.

The way the drug is mixed is different from what was originally approved.

In the case of antidepressants, they are instructed to add more active ingredients, which are the key.

Even unlicensed raw materials have been specified for additional input.

[신현호 / 의료법 전문 변호사 : 제조 방법이나 포장 방법, 또 들어가는 성분의 조금의 차이가 있어도 약이 독이 될 수가 있습니다. 이 때문에 약사법에서는 엄격히 규제하고 있어요.]

Companies that receive drugs from Company A are responsible for oversight, but they drew a line that they did not know anything.

[A 사 거래 제약사 관계자 : 저희 쪽에서 의뢰해서 특별하게 문제는 없었던 거 같다고.]

Medicines require a high degree of precision and do not tolerate any errors.

Experts were concerned that random manipulation of the raw material dose could cause serious side effects.

[오인석 / 대한약사회 학술이사 : 약물은 농도가 조금만 바뀌어도 해당 효과가 달라지는 거죠. 당뇨약도 마찬가지로 혈당 조절하는 부분에서 저혈당의 부작용이 올 수 있겠죠. 그런 경우에는 환자를 치료하는 데 큰 문제가 될 수 있으니까….]

Company A admitted that it had arbitrarily modified the manufacturing method to reduce deviations caused by aging facilities and facilities.

At the same time, he announced that he would voluntarily report it to the KFDA through self-investigation.

[A 사 관계자 : 식약처에 자진신고 하겠습니다. 해당 품목에 대해서 식약처 처분은 당연할 것 같습니다만 아마 해당 품목은 제조 정지나 허가취소가 될 것 같고요.]

Company A is a consignment producer of Sputnik V, a Corona 19 vaccine developed by Russia.

As the reliability question about Company A’s pharmaceutical manufacturing method is raised, the wave is likely to be difficult.

YTN Kim Woo-jun[[email protected]]is.

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